Government Notices

Archive for November, 2011

The FDA said in court filing that it is going to challenge an order that temporary halts a rule requiring cigarette manufacturers to put graphic images on packaging. The order, made by Judge Richard Leon, came after cigarette makers argued that the FDA rule violated their free-speech rights.

In June 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act into law, which empowered the FDA to regulate the manufacture and sale of tobacco products. The FDA issued a requirement that tobacco packaging display graphic images, including a cadaver on an autopsy table, a man with a hole in his throat, and diseased lungs. In August, Commonwealth Brands Inc., Liggett Group LLC., Lorillard, R.J. Reynolds, and Santa Fe Natural Tobacco Co. Inc., filed a lawsuit against the FDA, claiming the rule requiring the images violated the First Amendment of the US Constitution. The companies also said that it would cost nearly $20 million to meet the deadline for packaging changes. More FDA to Appeal Graphic Cigarette Warning Ban

US District Court Judge James Beaty has denied a motion to overturn a jury verdict that drugmaker Novartis failed to adequately warn consumers and physicians about the increased risks of severe jawbone damage associated with the bone-strengthening drugs Zometa and Aredia.

Novartis had filed the bid to overturn a verdict nearly one year ago in which the jury awarded $12.6 million to Rita Fussman who suffered jawbone damage while she was dying of breast cancer in 2009. The jury also awarded $287,000 in compensatory damages. The final award was reduced under North Carolina law to approximately $1.3 million. More Judge Denies Bid to Overturn Verdict Against Novartis Executives

The family of Vicky Caprice Mersereau, 26, has filed a lawsuit against Bayer Inc., after Mersereau died of a large pulmonary embolism allegedly caused by the oral birth control Yasmin. Over 10,400 lawsuits have been filed against Yasmin and sister pill Yaz in the United States.

Last month, the US Food and Drug Administration issued a warning stating that oral contraceptives that contain the hormone drospirenone increase the risk of blood clots by 74 percent over older birth control pills on the market. Yasmine and Yaz are ‘fourth generation” low dose hormonal contraceptives, and have been top sellers in the US and Canada. More First Yasmin Lawsuit Filed in Canada Following Young Woman’s Death

The U.S. Supreme Court has decided to hear a lawsuit filed by two GlaxoSmithKline employees who argue that the Fair Labor Standards Act guarantees overtime pay to pharmaceutical sales reps. The Department of Labor has backed the sales reps, saying they never actually sell anything to physicians, instead they push doctors to prescribe pharmaceuticals, and are therefore outside the FLSA overtime pay exemption.

“Neither physicians nor patients can purchase or order pharmaceuticals” from a drug company sales representative, the lead class action plaintiffs wrote in their Supreme Court petition. “There is no direct link between a [pharmaceutical sales representative’s] promotional efforts directed to a physician and the actual purchase of a pharmaceutical product.” More US Supreme Court to Consider Overtime Pay for Sales Representatives

Melissa Catalino has filed a lawsuit against American Pistachio Commodity Corp., dba Sunrise Commodities after Catalino and her 6-year-old daughter were sickened last month after eating pesto made with salmonella tainted pine nuts.

According to the lawsuit, the tainted pine nuts were purchased from Wegmans Food Markets around October 17. Catalino became sick on Oct. 19, and her daughter became sick on Oct. 21, and had to be admitted to Strong Memorial Hospital for emergency treatment. Both are still recovering from their illnesses. Wegmans recalled the pine nuts on October 26. More Third Lawsuit Filed Over Tainted Pine Nuts

The family of Matilda Blanche Gentzel has filed a lawsuit in Illinois Cook County Circuit Court against Eddie Bauer, Goldbug Inc., and the Target Corporation, alleging that a defective infant carrier sling that her father, George G. Gentzel II, was wearing, cut off baby Matilda’s breathing and caused her to die.

According to the lawsuit, baby Matilda died November 19, 2009, four days after the Eddie Bauer Sling & Hip Carrier forced her chin to her chest causing “positional asphyxia.” George Gentzel was unable to see that his daughter was in distress because of the way her was positioned in the carrier. More Lawsuit Says Defective Sling Killed Baby

The New York Times has reported that one of the men who was allegedly victimized by former Penn State assistant football coach Jerry Sandusky is seeking an injunction against Sandusky’s charity foundation, the Second Mile, to prevent the charity from transferring or divesting its assets. Court papers said the victim and others are planning to file lawsuits against the charity, which reported assets of more than $9 million in 2010.

According to the court papers, attorneys for at least 11 alleged victims will probably file civil claims against the Second Mile, and that officials of the charity are negligent for failing to report what they knew of earlier sexual abuse accusations against Sandusky over the course of several years. The New York Times reports that Grand Jury testimony indicated that the Second Mile learned of the concerns regarding Sandusky and sexually abusive contact with boys, including occasions when he showered with them, nearly ten years ago. <!–more–>

An attorney for Victim Four said that they “felt it was necessary to take this action after learning the organization was considering transferring its programs and not continuing its operations.” He also said that he and other attorneys “believe it is in the best interest of our clients, as well as the other victims, to ensure that the organization is being financially responsible.”

The injunction requests that assets of the charity “not be dissipated, encumbered or in any way obligated or disturbed in any form and should be available to victims of sexual abuse.”

A lawsuit filed against one of the country’s largest gypsum wallboard manufacturers, claiming the wallboard exhibited the same characteristics of the defective Chinese Drywall has been dismissed by Marshall County, Alabama Circuit Court Judge Tim Jolley.

When the federal Darvocet litigation was ordered to be centralized and consolidated in the U.S. District Court for the Eastern District of Kentucky as part of multidistrict litigation approximately three months ago, there were only 17 lawsuits filed.

Today, more than 100 lawsuits Darvocet and Darvon lawsuits have been filed in federal courts across the country, by plaintiffs who say the side effects of the drugs include potentially fatal heart rhythm alterations. More Darvocet Lawsuits Continue to Grow

U.S. District Judge Legrome D. Davis has sentenced three former Synthes Inc., executives to prison for being actively involved with the illegal promotion and clinical testing of the company’s Norian bone cement used by surgeons during back surgeries. Three patients died on the operating table during the procedures.

The former president of Synthes USA, Michael Huggins, 54, was sentenced to nine months. Thomas Higgins, 55, the former leader of the company’s spine division, was also sentenced to nine months, while the man in charge of regulatory affairs, John Walsh, 48, was sentenced to five months. All three will each pay $100,000 in fines. More Synthes Executives Sentenced to Prison

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